17/06/2024, 17:56 Diasorin Nabs 510(k) Clearance for Fungemia Panel | 360Dx

Diasorin Nabs 510(k) Clearance for Fungemia Panel

Jun 05, 2024 | staff reporter

Save for later

NEW YORK – Diasorin said on Wednesday that the firm has received US Food and Drug
Administration 510(k) clearance for a molecular test for common causes of fungemia.

The Saluggia, Italy-based firm's Liaison Plex Yeast Blood Culture Assay is used for the detection of
16 pathogens that are commonly associated with fungal bloodstream infections. Diasorin said that
fungal pathogens are a great concern because they can spread with ease between patients in
healthcare settings.

The test is the firm's second syndromic panel cleared for use on Diasorin's Liaison Plex instrument,
following the Liaison Plex Respiratory Flex Assay. The firm also has been developing Gram-positive
and Gram-negative blood culture panels for the diagnosis of bloodstream infections on the Liaison
Plex instrument.

"The Liaison Plex Yeast Blood Culture Assay adds to our already market-leading bloodstream
infection portfolio to provide a rapid solution for this critical disease state," Angelo Rago, president
of Diasorin's Luminex business, said in a statement. "The Liaison Plex enables clinical labs and
healthcare systems throughout the US to meet their diagnostic and antimicrobial stewardship needs
for better patient outcomes."

Diasorin CEO Carlo Rosa added that the firm is committed to expanding its multiplex test offerings
on the Liaison Plex system.

Diasorin announced in March that it had received clearance for the Liaison Plex platform, which is
used for syndromic testing. It incorporates a pricing model that allows users to pay for a portion or
all of the results. The instrument allows the use of direct DNA detection or PCR amplification, and it
is a replacement for the Verigene sample-to-answer benchtop instrument that Diasorin acquired
with its 2021 acquisition of Luminex.

Filed Under Molecular Diagnostics Infectious Disease PCR

Regulatory News & FDA Approvals Business News Europe

North America DiaSorin fungal infections

Privacy Policy. Terms & Conditions. Copyright © 2024 GenomeWeb, a business unit of Crain
Communications. All Rights Reserved.

https://www.360dx.com/molecular-diagnostics/diasorin-nabs-510k-clearance-fungemia-panel 1/1